Urinary drainage bags are conventionally used in hospitals and health care facilities when it is necessary to collect urine from a catheterized patient over an extended period of time. Such bags are routinely used by post-operative patients as well as those with urological disorders for collection, measuring, and testing the frequency of urinary output. Urinary drainage systems typically include a catheter with tubing attached thereto, connected to a collection bag made of a polymeric material such as a PVC film. The collection bag generally includes a component for emptying the bag, such as a drainage tube. In operation, the patient is first catheterized, and the catheter is then connected to the drainage bag through a length of tubing. The bag is normally supported either from the bed rail or other support structure (usually below the level of the patient), the urine draining through the catheter, the tubing, and then finally into the bag due to gravitational forces. Most bags are provided with drain ports through which measured quantities of urine can be removed for various testing procedures.
Typical urine drainage bags are described in U.S. Pat. No. 3,650,272 (titled “Drainage Bag,” issued Mar. 21, 1972), U.S. Pat. No. 4,312,352 (titled “Hanger, hook and handle assembly for urinary drainage bag,” issued Jan. 26, 1982), U.S. Pat. No. 4,313,447 (titled “Collection bag,” issued Feb. 2, 1982), U.S. Pat. No. 4,386,930 (titled, “Collection device for body fluids with antiseptic pump,” issued Jun. 7, 1983), U.S. Pat. No. 4,443,219 (titled “System for aseptically draining a urine bag,” issued Apr. 17, 1984), U.S. Pat. No. 4,452,253 (titled, “Collection bag,” issued Jun. 5, 1984), U.S. Pat. No. 4,659,329 (titled, “Liquid drainage system,” issued Apr. 21, 1987), U.S. Pat. No. 4,723,950 (titled, “Urine drainage bag outlet with barrier against microbial infection,” issued Feb. 9, 1988), U.S. Pat. No. 5,375,799 (titled, “Collection bag hanger with rail width-adjustable hook arms,” issued Dec. 27, 1994), and U.S. Pat. No. 5,454,798 (titled, “Disposable urine bag,” issued Oct. 3, 1995), each of which is herein incorporated by reference in its entirety.
One of the potential drawbacks with typical urine collection bags is the possibility of contamination and infection to the patient. In particular, when the bags are opened to remove some or all of the urine, air may be permitted to enter into the outlet spout, allowing bacteria to migrate up the spout into the bag, and finally into the bladder, causing infection. Additionally, there may be the problem of contamination of hospital personnel due to leakage or splattering of urine during the collection process. Urine may also collect in the tubing connecting the catheter to the urine collection bag, referred to as urine stasis or hold up within the tubing. For example, urine may stand in the tubing because the pressure expelling the urine down the tube into the collection bag is less than the pressure required to empty the tubing into the collection bag.
In traditional urine collection systems, urine is moved from the catheter into the collection bag solely due to gravitational forces. Thus, evacuation of urine from the catheter and/or tubing may be prevented when the tubing pathway is not directed downward (e.g., if the tubing is lying flat, or if a portion of the tubing is not above the collection bag). Urine collection within the tubing is undesirable and may contribute to infection, spilling and/or urine reflux. Furthermore, some urine collection systems analyze urine from urine collected in the collection bag, meaning that urine collected within the catheter and/or tubing may prevent accurate measurement/analysis. On average, about 80-90 mL of urine are produced in 1 hour. This is approximately the same volume required to fill the current commercially available drainage tubing. Standing urine in the tubing is undesirable both from a possible retrograde infection standpoint and because it necessitates spending time and resources to clear the tubing. It is hypothesized that not having collected urine in the tubing will aid in infection control and reduce patient exposure and hospital costs.